Trastuzumab (Herceptin) is a monoclonal antibody treatment option for breast cancer patients costing up to 5-10 times more than state-of-the-art chemotherapy. A significantly improved outcome for defined groups of patients who are HER2/neu-positive was previously shown for advanced/metastatic breast cancer and recently also for adjuvant therapy in several large phase III trials. However, financial limitations of any health system, even in wealthy nations such as Germany, can prevent optimal treatment. The German Social Security Code requires cost-effectiveness of all medical treatment. Financing of off-label pharmaceuticals is strictly limited by law. In contrast to advanced breast cancer for which trastuzumab is licensed, in the adjuvant setting it is restricted to off-label use and could result in a massive financial loss for the health care provider. So, indication and reimbursement for innovative therapies during the interim phase between clinical trials and official approval remain difficult. In this review, the current situation in Germany and the experience with financing and reimbursement of the costs of trastuzumab in the adjuvant and advanced setting as well as the search for financial solutions are described.     «

Trastuzumab (Herceptin) is a monoclonal antibody treatment option for breast cancer patients costing up to 5-10 times more than state-of-the-art chemotherapy. A significantly improved outcome for defined groups of patients who are HER2/neu-positive was previously shown for advanced/metastatic breast cancer and recently also for adjuvant therapy in several large phase III trials. However, financial limitations of any health system, even in wealthy nations such as Germany, can prevent optimal trea...     »